The European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation for CG367, an investigational treatment for Bronchiolitis Obliterans Syndrome (BOS), according to manufacturer Therabron Therapeutics Inc.
BOS is a distinct complication following lung transplantation. It leads to fibrosis of airways in transplanted lungs, followed by significant functional loss, obliteration of the terminal airways and, eventually, death.
“We are pleased to have received Orphan Drug Designation from the EMA to treat patients diagnosed with BOS following lung transplantation. This is an extremely serious and potentially deadly complication of lung transplantation, which generally manifests between 18 months to four years after the procedure,” explained Vinzenz Ploerer, CEO of Therabron.
“The condition is, unfortunately, refractory to most forms of interventions and therefore represents the most common cause of death for this patient population. We believe that CG367 holds promise as a potentially important therapeutic option and we look forward to working with the EMA as we progress clinical development for this indication,”
In addition to CG367, Therabron’s lead product candidate, CG100, in development for the prevention of chronic respiratory morbidity (CRM) in premature infants, has also been granted Orphan Drug Designation by both the US FDA and the EMA.